[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iv-sinonasal-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iv-sinonasal-cancer-ajcc-v8":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,72,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100566967","remote-audiometry-to-monitor-for-treatment-related-hearing-loss-in-patients-with-hn-scc-receiving-cisplatin-andor-radiation-100566967",false,"NCT06662058","Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and\u002For Radiation","Ototoxicity Monitoring and Remote Audiometry","Inclusion Criteria:\n\n* Adult patients, male or female, aged ≥ 18, able to provide informed consent\n* Subjects with pathologically proven HNSCC involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, skin, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can also be included. Patients can have previously untreated or recurrent\u002Fmetastatic disease\n* Subjects who will be treated with cisplatin chemotherapy and\u002For radiation. For radiation alone, patients should have tumors near the inner ear, including the nasopharynx, temporal bone, and\u002For parotid salivary gland\n* Life expectancy of more than 3 months, as determined by the investigator\n\nExclusion Criteria:\n\n* Patients with profound hearing loss in both ears, which precludes an accurate hearing test. This can be determined based on patient report\u002Fhistory or audiogram done before or after informed consent\n* Patients who are unable to participate in a hearing test (per the investigator's judgment)","ALL","18 Years",{"count":19,"type":20},118,"ESTIMATED","INTERVENTIONAL",[23],"NA","This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and\u002For radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and\u002For radiation.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58],"Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Cutaneous Squamous Cell Carcinoma of the Head and Neck","Head and Neck Carcinoma of Unknown Primary","Head and Neck Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Metastatic Cutaneous Squamous Cell Carcinoma of the Head and Neck","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hypopharyngeal Squamous Cell Carcinoma","Metastatic Laryngeal Squamous Cell Carcinoma","Metastatic Nasopharyngeal Squamous Cell Carcinoma","Metastatic Oral Cavity Squamous Cell Carcinoma","Metastatic Oropharyngeal Squamous Cell Carcinoma","Metastatic Paranasal Sinus Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Paranasal Sinus Squamous Cell Carcinoma","Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck","Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Hypopharyngeal Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Nasopharyngeal Squamous Cell Carcinoma","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","Recurrent Paranasal Sinus Squamous Cell Carcinoma","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Hypopharyngeal Carcinoma AJCC v8","Stage IV Laryngeal Cancer AJCC v8","Stage IV Lip and Oral Cavity Cancer AJCC v8","Stage IV Nasopharyngeal Carcinoma AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IV Sinonasal Cancer AJCC v8","RECRUITING","2026-04-20",{"date":62,"type":63},"2026-04-23","ACTUAL",{"date":65,"type":63},"2025-03-12",{"date":67,"type":20},"2029-10-31",{"name":69,"class":70},"Emory University","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100582832","phase-1-tmv-vaccine-therapy-alone-and-with-pembrolizumab-for-the-treatment-of-recurrent-andor-metastatic-head-and-neck-squamous-cell-cancer-100582832","NCT06868433","TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and\u002For Metastatic Head and Neck Squamous Cell Cancer","Phase 1b Study of TMV Vaccine Therapy Alone and TMV Vaccine Plus Pembrolizumab for Recurrent and\u002For Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Must be at least ≥ 18 years of age\n* Histologically proven squamous cell carcinoma of the head and neck (HNSCC), amenable to salvage surgery. p16 positive and negative allowed. Squamous cell carcinoma of the oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, sinonasal carcinoma and cancer of unknown primary (squamous cell carcinoma only) are all allowed. They will be allowed to have up to 3 different regimens after diagnosed of recurrent or metastatic HNSCC\n* Oropharyngeal tumors must have p16 or human papillomavirus (HPV) testing done\n* The tumor tissues must be available and banked (- 80°C) at the time of salvage surgery (1st informed consent form \\[ICF\\] must be signed)\n* Recurrent and\u002For metastatic HNSCC that has failed standard chemotherapy and immunotherapy. Eligible subjects must have progressed on ≥ 2 lines of standard of care prior to starting trial therapy. For patients who have relapsed within 6 months of systemic therapy given with curative intent, that therapy will count as a line of metastatic therapy. Eligible subjects will have no restriction on prior lines of therapy in the metastatic\u002Fadvanced disease setting\n* The tumors should be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n* Must have enough tissue collected after salvage surgery to make at least 3 doses of vaccine (minimum weight of the resectable tumor tissue is ≥ .5 grams) and adequate cellularity (\\> 40% cellularity) assessed by the head and neck pathologists\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n* Absolute neutrophil count ≥ 1,500 cells\u002FuL\n* Platelets ≥ 100,000\u002FuL\n* Hemoglobin ≥ 9.0g\u002FdL (may receive packed red blood cell \\[prbc\\] transfusion)\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Albumin ≥ 3.0 g\u002FdL\n* Serum creatinine ≤ 1.5 x ULN\n* Calculated creatinine clearance of ≥ 50 mL\u002Fmin\n* International normalized ratio (INR) ≤ 1.5. Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving low molecular weight (LMW) heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level \\\u003C 1.1U\u002FmL are allowed on the trial\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n* Ability to understand and willingness to sign written informed consent documents\n* Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion\n* Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion\n* Female subjects of childbearing age must have a negative serum pregnancy test at study entry\n* Patients who have received prior pembrolizumab are eligible\n\nExclusion Criteria:\n\n* Salivary tumors and non-squamous cell histology in head and neck cancer\n* Not enough tissue collected after surgery for a planned 3 doses (weight of the resectable tumor tissue is less than 1.0 gram)\n* Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)\n* Prior organ allograft or allogeneic bone marrow transplantation\n* Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma\u002Fatopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Women who are pregnant or lactating, and child-bearing potential women without adequate contraception\n* Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Other medications, or severe acute\u002Fchronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study\n* Clinical evidence of bleeding diathesis or coagulopathy\n* Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for \\> 5 years. Patients with prior in situ carcinomas are eligible provided there was complete removal\n* Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment\n* Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration\n* History of severe hypersensitivity reactions to other monoclonal antibodies\n* Non-oncology vaccines within 28 days prior to planned treatment",{"count":80,"type":20},40,[82],"PHASE1","This phase Ib trial tests the safety, side effects and best dose of tumor membrane vesicle (TMV) vaccine therapy alone and in combination with pembrolizumab and evaluates how well it works in treating patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Vaccines made from a person's tumor cells, such as TMV vaccines, may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving TMV vaccine therapy alone or with pembrolizumab may be safe, tolerable and\u002For effective in treating patients with recurrent and\u002For metastatic head and neck squamous cell cancer.",[26,33,34,35,36,37,38,85,45,46,47,48,49,50,86,87,52,53,54,55,56,57,58],"Metastatic Sinonasal Squamous Cell Carcinoma","Recurrent Sinonasal Squamous Cell Carcinoma","Squamous Cell Carcinoma of Unknown Primary",[89],"Recurrent or metastatic head and neck cancer whose tumor should have banked at the time of surgery.","2026-03-02",{"date":92,"type":63},"2026-03-04",{"date":94,"type":63},"2025-05-08",{"date":96,"type":20},"2028-12-31",{"name":69,"class":70},2,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":119,"locationsCount":98},"100565019","phase-2-lovastatin-and-pembrolizumab-for-the-treatment-of-patients-with-recurrent-or-metastatic-head-and-neck-cancer-lapp-trial-100565019","NCT06636734","Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial","A Phase II Trial Of Lovastatin And Pembrolizumab In Patients With RM HNSCC (LAPP)","Inclusion Criteria:\n\n* Adult patients, male or female, aged ≥ 18, able to provide informed consent\n* Subjects with pathologically proven, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can be included if human papillomavirus (HPV)-positive\n* PD-L1 combined positive score (CPS) ≥ 1 (i.e., must be a candidate for treatment with pembrolizumab alone)\n* Patients must not be under consideration for salvage surgery\n* Measurable disease by RECIST 1.1 criteria\n* Life expectancy of more than 3 months, as determined by the investigator\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Recovery to baseline or ≤ grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0 from toxicities related to any prior treatments, unless adverse events are clinically non-significant and\u002For stable on supportive therapy\n* For men or women of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks after the end of lovastatin\u002Fpembrolizumab administration\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 without colony stimulating factor support\n* Platelets ≥ 100,000\u002Fmm\\^3\n* Hemoglobin ≥ 9 g\u002FdL\n* Bilirubin ≤ 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg\u002FdL\n* Serum albumin ≥ 2.8 g\u002Fdl\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN\n* Serum phosphorus, calcium, magnesium and potassium ≥ lower limit of normal (LLN)\n\nExclusion Criteria:\n\n* Patients already taking a statin drug\n* Liver dysfunction precluding the use of statins\n* Radiation to the head and neck or other sites within 4 weeks prior to enrollment\n* Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment\n* Prior treatment with immune checkpoint blocking therapy\n* Current use of drugs that interact with lovastatin (cimetidine, spironolactone, ketoconazole, and others)\n* Pregnancy, lactation, or plan to become pregnant\n* Inability to swallow lovastatin tablets\n* Known allergy or prior adverse reaction to lovastatin, other statin drugs, or pembrolizumab",{"count":107,"type":20},28,[109],"PHASE2","This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death. In addition, studies have shown that lovastatin may make the tumor cells more sensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lovastatin and pembrolizumab may kill more tumor cells in patients with recurrent or metastatic head and neck cancer.",[26,112,33,34,35,36,37,38,39,45,46,47,48,49,50,51,53,54,55,56,57,58],"Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary","2026-02-08",{"date":115,"type":63},"2026-02-11",{"date":117,"type":63},"2024-12-09",{"date":96,"type":20},{"name":69,"class":70}]